Hobson Prior is seeking a Drug Safety Physician for a contract role based in Allschwil, Switzerland. The successful candidate will be responsible for all aspects of safety related to assigned products, including reviewing and assessing post-marketing adverse event reports, aggregate reporting, signal detection, risk management, and risk minimization activities.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Oversee all safety-related aspects of assigned products.
• Lead the Safety Management Team for assigned products.
• Monitor, evaluate, interpret and manage safety information.
• Prepare periodic safety reports and contribute to other key regulatory safety documents.
• Review adverse event reports for assigned projects/products to ensure proper coding, seriousness, expectedness and causality assessment.
• Respond to safety inquiries from regulatory authorities and support the management of safety inquiries from health care professionals.
• Support licensing agreements as needed.
• Work closely with Quality Management in the review of technical product complaints associated with an adverse event for assigned projects/products.

Requirements

• Medical degree.
• Experience in global drug safety in the pharmaceutical or biotechnology industry.
• Knowledge of post-marketing adverse experience reporting systems, product safety monitoring and preparation of post-marketing regulatory safety reports/documents.
• Knowledge of global safety regulations, Good Clinical Practice (GCP), Good pharmacovigilance Practice (GVP), and Pharmacovigilance compliance requirements.
• Experience with key safety documents such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Risk Management Plan (RMP), Company Core Data Sheet (CCDS) etc.
• Experience with safety signal identification methodology and risk minimization measures.
• Excellent medical writing skills.
• Good presentation skills.
• Excellent interpersonal, communication and negotiation skills.
• Good organizational and planning capabilities and ability to meet timelines.
• Experience with Argus Safety database is preferable.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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